TAIPEI, Taiwan, Dec. 7 /PRNewswire-Asia/ -- TaiGen Biotechnology Co., Ltd. announced today the presentation of Phase I and preclinical data for TG-0054, the Company's chemokine receptor CXCR4 antagonist and a novel, potent stem cell mobilizer, at the ASH Annual Meeting held in New Orleans, the US, from December 5 to 8, 2009.
The clinical data of Phase 1 study will be presented. In this randomized, double-blind, placebo-controlled, sequential ascending single intravenous dose study, TG-0054 exhibited excellent and favorable safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) profile. A maximally tolerated dose (MTD) was established. Good tolerability was observed. PK parameters showed dose proportionality over the dose range studied. PD results showed potent, dose-dependent mobilization of CD34+ hematopoietic stem cells and CD133+ endothelial progenitor cells into peripheral blood circulation.
The preclinical data will be reported on in vitro assays and in vivo studies in mouse models. TG-0054 demonstrated potent and selective antagonistic activities against CXCR4 in vitro. Significant mobilization of CD34+ hematopoietic stem cells and CD133+ endothelial progenitor cells was observed when TG-0054 was used alone or combined with G-CSF in preclinical models.
The preclinical and Phase I results support further clinical investigation. The Phase 2 study entitled "A Phase II, Randomized, Open-Label, Multi-Center Study to Evaluate the Safety, Pharmacokinetics, and Hematopoietic Stem Cell Mobilization of TG-0054 in Patients with Multiple Myeloma, Non-Hodgkin Lymphoma or Hodgkin Disease" will begin to enroll patients in December, 2009.
About TaiGen Biotechnology
TaiGen Biotechnology ( http://www.taigenbiotech.com/ ) is a leading development stage pharmaceutical company based in Taiwan with a wholly-owned subsidiary in Beijing, China. The company has a full capacity in discovery research and clinical development in China/Taiwan/US. Its current pipeline includes therapeutics for infectious diseases, diabetic complications and cancer for the worldwide market. In addition to TG-0054, Nemonoxacin, a novel broad-spectrum non-fluorinated quinolone with anti-MRSA activity and in-licensed from P&G Pharmaceuticals, achieved non-inferiority in clinical cure rate and safety profile compared with Levofloxacin in its Phase II CAP trial. The company has completed a second phase II study in diabetic foot infection to demonstrate Nemonoxacin's anti-MRSA activity with once-a-day oral dosing. TaiGen is seeking Nemonoxacin licensees for the US, EU and Japan markets. TaiGen also has HCV protease inhibitors in advanced preclinical programs to treat chronic hepatitis C infection.
CONTACT: Dr. John Jin, VP Global Business Development of TaiGen
Biotechnology Co., Ltd., +886-2-2790-1861, firstname.lastname@example.org
Web site: http://www.taigenbiotech.com//